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A Medication Adherence Intervention for HIV Infected Veterans
This study has been completed.
First Received: March 14, 2001   Last Updated: May 11, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013065
  Purpose

It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently.


Condition
HIV Infection

Study Type: Observational
Study Design: Prospective
Official Title: A Medication Adherence Intervention for HIV Infected Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 210
Study Completion Date: December 2003
Groups/Cohorts
1

Detailed Description:

Background:

It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently.

Objectives:

Optimizing health for HIV patients requires excellent adherence to antiretroviral medication regimens. However, its unclear how best to incorporate adherence education and support programs into VA HIV outpatient care. We implemented and evaluated a pharmacist program (ACE) and a Pager reminder program to support adherence in veterans with HIV.

Methods:

We used a quasi-experimental design with pre-post evaluation at four VA Centers. Three treatment conditions (ACE, Pager, Usual Care) were rolled-in sequentially over two study phases, allowing for group comparisons between conditions. ACE is a multi-component manualized 4-session, individual patient education and support program by trained pharmacists. The Pager intervention used alphanumeric pagers to remind patients of dosing times.

Electronically-monitored medication adherence (MEMS), self-report questionnaires, and pharmacy refill records were collected. Qualitative site interviews were collected before and after interventions to assist with program evaluation. Multilevel mixed models were used to analyze main study outcomes over time. Secondary analyses compared subgroup who actually received all ACE sessions (�as treated�) to controls.

Status:

Project has been completed and Final Report submitted to HSR&D CO.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must be greater than or equal to 18 years old, must be enrolled in HIV Primary care at one of 4 VA study sites and be taking antiretroviral therapy.

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00013065

Locations
United States, Arizona
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723-0001
United States, California
VA Greater Los Angeles Healthcare System, West LA
Los Angeles, California, United States, 90073-1002
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1207
VA San Diego Health Care System
San Diego, California, United States, 92161
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Be
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Investigators
Principal Investigator: Allen L. Gifford, MD Edith Nourse Rogers Memorial Veterans Hospital, Be
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Gifford, Allen - Principal Investigator )
Study ID Numbers: HII 99-054
Study First Received: March 14, 2001
Last Updated: May 11, 2009
ClinicalTrials.gov Identifier: NCT00013065     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on July 02, 2009